Cleared Traditional

K914877 - IL TEST(TM) UREA NITROGEN

K914877 is the FDA 510(k) clearance for IL TEST(TM) UREA NITROGEN by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K914877 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
134d
Days
Class 2
Risk

K914877 is an FDA 510(k) clearance for the IL TEST(TM) UREA NITROGEN. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 11, 1992 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K914877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1991
Decision Date March 11, 1992
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 73
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K914877.
OLYMPUS BUN REAGENT
K924693 · Olympus Corp. · Nov 1992
MILES URINE UREA NITROGEN METHOD
K923035 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS UREA NITROGEN (BUN) REAGENT
K922597 · Olympus Corp. · Jul 1992
UREA NITROGEN TEST
K903334 · Em Diagnostic Systems, Inc. · Sep 1990
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
K901123 · Technicon Instruments Corp. · May 1990
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583
K900394 · American Research Products Co. · Apr 1990